Vibrational oral appliance with mandibular advancements

ABSTRACT

Described herein is an oral appliance. The oral appliance includes upper and lower trays that each include at least one axial spring configured to contact a palatal/lingual surface of at least one tooth, where each axial spring is coupled to the respective upper or lower tray, and where each axial spring is configured to produce and transmit intermittent, cyclic forces to the palatal/lingual surface of the tooth to promote palatal and upper/lower jaw development. The upper and lower trays each include an expansion mechanism to enable adjustment of the size of the upper and lower trays to account for palatal expansion and upper and lower jaw development. The oral appliance includes first and second adjustable positioners positioned on the upper tray and fins formed integrally on the lower tray so that the oral appliance advances the mandible to provide temporary relief from sleep disordered breathing, sleep apnea and/or snoring.

FIELD OF DISCLOSURE

The present disclosure is directed to an oral appliance. The oralappliance advances the mandible to provide temporary relief from sleepdisordered breathing, sleep apnea and/or snoring.

BACKGROUND

Sleep apnea is a serious, chronic disease that adversely impactsmillions of people. Over the years, many treatments and devices havebeen developed to help patients deal with the symptoms of sleep apnea.In addition, some researchers have devoted time and energy to findingways to attack the root cause of the disease. For example, U.S. Pat. No.7,887,324 describes a protocol for correcting common orthodontic andcraniofacial abnormalities that lead to sleep apnea and other breathingdisorders. The protocol of U.S. Pat. No. 7,887,324 uses a vibrationalorthopedic-orthodontic appliance that induces craniofacial homeostasisby triggering a patient's genome. This treatment protocol changes theshape of the airway and upper and lower jaws of the patient. As a resultof the treatment, a patient's breathing disorder could be significantlyreduced in a life-changing way.

However, this protocol to correct the airway and jaw of the patienttakes some time. During treatment, the patient still suffers from abreathing disorder and needs short term relief. Many devices for shortterm relief are available on the market, including devices that forcethe advancement of the mandible during sleep. Yet because the applianceof U.S. Pat. No. 7,887,324 is worn at night, its use conflicts withusing other devices for short-term relief while sleeping. Moreover,adaptations of the appliance of U.S. Pat. No. 7,887,324 to provide shortterm relief have drawbacks.

Therefore, there is a need in the art for an improved device thatprovides short term relief from breathing disorders and also addressesthe root cause of the disease.

The present disclosure provides an oral appliance that provides shortterm relief from breathing disorders and also addresses the root causeof the disease. In particular, the oral appliance advances the mandibleto provide temporary relief from sleep disordered breathing, sleep apneaand/or snoring.

BRIEF DESCRIPTION OF THE DISCLOSURE

In one aspect, provided herein is an oral appliance comprising:

an upper tray configured to be positioned over an upper dental arch of apatient, the upper tray including first and second adjustablepositioners located bilaterally on a buccal side of a posterior of theupper tray wherein the first adjustable positioner extends from theright-side of the upper tray and the second adjustable positionerextends from the left-side of the upper tray; and

a lower tray configured to be positioned over a lower dental arch of thepatient, the lower tray including first and second fins positionedbilaterally on a labial side of an anterior of the lower tray whereinthe first fin extends from the right-side of the lower tray and thesecond fin extends from the left-side of the lower tray;

wherein the first and second adjustable positioners are eachindividually configured to be adjusted to provide a desired amount ofmandibular advancement when the first and second adjustable positionersengage with the first and second fins, respectively;

wherein the upper and lower trays are each individually coupled to atleast one axial spring configured to contact a palatal/lingual surfaceof at least one tooth, wherein the at least one axial spring of theupper tray and the at least one axial spring of the lower tray are eachindividually configured to produce and transmit intermittent, cyclicforces to the palatal/lingual surface of the at least one tooth; and

wherein the upper and lower trays each individually comprise at leasttwo sections coupled by an expansion mechanism to enable adjustment ofthe size of the upper and lower trays to account for palatal expansionand upper and lower jaw development.

In another aspect, provided herein is an oral appliance comprising:

an upper tray configured to be positioned over an upper dental arch of apatient, the upper tray including first and second adjustablepositioners located bilaterally on a buccal side of a posterior of theupper tray wherein the first adjustable positioner extends from theright-side of the upper tray and the second adjustable positionerextends from the left-side of the upper tray; and

a lower tray configured to be positioned over a lower dental arch of thepatient, the lower tray including first and second fins locatedbilaterally on a labial side of an anterior of the lower tray whereinthe first fin extends from the right-side of the lower tray and thesecond fin extends from the left-side of the lower tray;

wherein the first and second adjustable positioners each individuallycomprise a screw mechanism coupled to a spacer, wherein each screwmechanism is configured to set a position of the spacer to which it iscoupled;

wherein the position of the spacer provides a desired amount ofmandibular advancement when the first and second adjustable positionersengage with the first and second fins, respectively;

wherein the upper tray and the lower tray each individually comprise atleast one axial spring configured to contact a palatal/lingual surfaceof at least one tooth, wherein the at least one axial spring of theupper tray and the at least one axial spring of the lower tray are eachindividually coupled to the respective lower tray or upper tray, whereinthe at least one axial spring of the upper tray and the at least oneaxial spring of the lower tray are each individually configured toproduce and transmit intermittent, cyclic forces to the palatal/lingualsurface of the at least one tooth; and

wherein the upper tray and the lower tray each individually comprise atleast two sections coupled by an expansion mechanism to enableadjustment of the size of the upper tray and the lower tray to accountfor palatal expansion and upper and lower jaw development.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present invention can be more easily understood andfurther advantages and uses thereof more readily apparent, whenconsidered in view of the description of the various embodiments and thefollowing figures in which:

FIG. 1A is a perspective view of an oral appliance shown positioned on aset of teeth according to one embodiment of the present invention.

FIG. 1B is a perspective view of the oral appliance of FIG. 1A.

FIG. 2 is a perspective view of one embodiment of an upper tray of theoral appliance of FIG. 1 .

FIG. 3A is a bottom view of the upper tray of FIG. 2 .

FIG. 3B is a top view of an upper tray of the oral appliance of FIG. 1with a first palatal expansion system according to one embodiment of thepresent invention.

FIG. 3C is a top view of an upper tray of the oral appliance of FIG. 1with a second palatal expansion system according to one embodiment ofthe present invention.

FIG. 4 is a perspective view of one embodiment of a lower tray of theoral appliance of FIG. 1 .

FIG. 5 is a bottom view of the lower tray of FIG. 4 .

FIG. 6A is a front view of a three dimensional (3-D) axial springaccording to one embodiment of the present invention.

FIG. 6B is a perspective view of a three dimensional (3-D) axial springaccording to one embodiment of the present invention.

FIG. 6C is a side view of a three dimensional (3-D) axial springaccording to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE DISCLOSURE

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which is shown byway of specific illustrative embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice the invention, and it is tobe understood that other embodiments may be utilized, and that logical,mechanical, and electrical changes may be made without departing fromthe scope of the present invention. The following detailed descriptionis, therefore, not to be taken in a limiting sense.

Oral Appliance: Overview

Oral appliances in accordance with the present disclosure provide shortterm relief from breathing disorders and also address the root cause ofthe disease. Generally, the oral appliances advance the mandible toprovide temporary relief from sleep disordered breathing, sleep apneaand/or snoring.

FIG. 1A depicts a perspective view of one embodiment of a vibrationaloral appliance with mandibular advancement, indicated generally at 100,and constructed according to the present invention. Oral appliance 100is designed to perform at least two functions. First, oral appliance 100uses vibrational elements (such as 3-D axial springs, as described inmore detail below) to promote palatal and upper/lower jaw development.This function makes physical changes to the patient for long-termcorrection of breathing disorders. Second, oral appliance 100 isconfigured to be used as a sleep aide to provide immediate relief forpatients suffering from sleep-disordered breathing, including, but notlimited to, obstructive sleep apnea (OSA) and snoring. To accomplishthis, oral appliance 100 includes a mechanism for mandibularadvancement. In some embodiments, this mechanism uses a fin and screwmechanism that controls the relative position of the upper and lowerjaws of the patient (referred to as mandibular advancement). Thus, thesame oral appliance performs two functions: (1) it promotes palatal andupper/lower jaw development, and (2) it provides mandibular advancementfor temporary relief from symptoms of sleep-disordered breathing and/orsleep apnea.

In some embodiments, oral appliance 100 includes an upper tray 102 and alower tray 104. Generally, upper tray 102 is configured to be positionedover an upper dental arch 106. Generally, lower tray 104 is configuredto be positioned over a lower dental arch 108.

Generally, upper tray 102 and lower tray 104 are held in place with anysuitable means known in the art. In some embodiments, upper tray 102 andlower tray 104 are held in place with labial bows 122. In someembodiments, labial bow 122 is formed of an arch wire that wraps aroundthe front of the teeth.

In some embodiments, oral appliance 100 uses three-dimensional (3-D)axial springs 126 and an expansion mechanism 128 to promote correctionto the airway and upper and lower jaw of the patient using thetechniques described in U.S. Pat. No. 7,887,324. U.S. Pat. No. 7,887,324is incorporated herein by reference. One example of an expansionmechanism 128 is shown in FIG. 3A. One embodiment of 3-D axial springsis described below and is shown in FIGS. 6A-6C. In some embodiments,lower tray 104 includes fins, such as fins 116-A and 116-B, that engageadjustable positioners 114 on upper tray 102 to control mandibularadvancement for temporary relief from sleep apnea, snoring, and/orsleep-disordered breathing.

Upper Tray of Oral Appliance

As shown in FIG. 2 , upper tray 102 includes base plate 130. Generally,base plate 130 is formed of any suitable material for manufacture oforal appliances known in the art. In some embodiments, base plate 130 isformed of a hard acrylic material.

In some embodiments, base plate 130 is formed from one part, two parts,three parts, or more than three parts. In some embodiments, the part(s)of base plate 130 are adjustable with an expansion mechanism. Generally,the expansion mechanism may be selected from any suitable expansionmechanism known in the art. In some embodiments, the expansion mechanismis configured to enable upper tray 102 to change in size to accommodategrowth and changes in the upper dental arch/palate of the patient. Insome embodiments, the expansion mechanism is selected from jackscrews,wires, wires bent with omega-shaped loops, and combinations thereof.

In some embodiments, the part(s) of base plate 130 are adjustable withat least one jackscrew. In some embodiments, the part(s) of base plate130 are adjustable with at least two jackscrews.

In the embodiments shown in FIG. 2 and FIG. 3A, base plate 130 is formedin three parts, namely left part 130-A, right part 130-B and center part130-C. As shown in FIG. 3A, left part 130-A and right part 130-B of baseplate 130 are connected by an intervening midline jackscrew 128 thatenables upper tray 102 to expand to account for palatal growth due tothe use of 3-D axial springs 126. Additionally, in this embodiment,upper tray 102 also includes jackscrew 132 that couples center part130-C to the rest of base plate 130 to account for changes in the frontof the patient's upper dental arch. By adjusting jackscrew 132, centerpart 130-C of base plate 130 moves anteriorly and posteriorly to fitupper tray 102 to the patient's dental arch. Similarly, by adjustingjackscrew 128, left and right parts 130-A and 130-B move away from ortoward the centerline of the dental arch to further fit the upper trayto the dental arch of the patient. The expansion mechanisms illustratedby jackscrews 128 and 132 are shown by way of example and not by way oflimitation.

In some embodiments, such as the embodiment shown in FIG. 3A, base plate130 also includes extensions or overlays 137 of the plate body thatsymmetrically overlay the biting (occlusal) surfaces of at least two ofthe patient's teeth in the space where those teeth would normallycontact the opposing teeth from the lower jaw. The thickness of theocclusal coverage ranges from approximately 0.5 mm to approximately 5.0mm, as determined by orthodontic equilibration, and may be absent incertain locations or spots, if required. The base plate body itself hasa thickness that varies, and ranges from about 1.0 mm to about 5.0 mm,depending upon the components embedded within it.

In some embodiments, the base plate 130 of upper tray 102 is configuredin other ways to accommodate changes in the palate and upper and lowerjaw. In some embodiments, the base plate 130 includes one portion, twoportions, three portions, or more than three portions. In someembodiments, the base plate 130 is divided into four portions such asshown, for example, in FIG. 3B and FIG. 3C. In the embodiment shown inFIG. 3B, the posterior of base plate 130 is divided into two halves:first portion 130-A and second portion 130-B. First half 130-A andsecond half 130-B are interconnected by an intervening jackscrewassembly 128. Additionally, the anterior portion of base plate 130 isalso divided into two halves: third portion 130-C1 and fourth portion130-C2. Third portion 130-C1 is interconnected with second portion 130-Bby intervening jackscrew assembly 129-2. Fourth portion 130-C2 isinterconnected with first portion 130-A by intervening jackscrewassembly 129-1. In yet another embodiment, shown in FIG. 3C, base plate130 includes first and second portions 130-A and 130-B that areinterconnected by an expansion mechanism 128. In this embodiment,expansion mechanism 128 is a wire bent with an omega-shaped loop toallow expansion of the upper tray 102. Additionally, base plate 130 alsoincludes third and fourth portions 130-C1 and 130-C2 that areinterconnected by expansion mechanism 129. In this embodiment, expansionmechanism 129 is a wire bent with an omega-shaped loop to allow forfurther expansion of upper tray 102.

In some embodiments, for example as shown in FIG. 1A, the upper tray 102also includes at least one adjustable positioner 114 that controlsmandibular advancement for oral appliance 100. In some embodiments,adjustable positioners 114 include screw mechanism (e.g., a jackscrew)180 that is coupled to spacer 182. The relative position of spacer 182is established by adjusting screw mechanism 180. By adjusting screwmechanism 180, spacer 182 is moved forward or backward to set the amountof mandibular advancement required by the patient. In some embodiments,for example as shown in FIG. 1A, spacer 182 includes an inclined surface184 that is configured to engage a corresponding surface of acounterpart fin 116, thereby locking the relative positions of the uppertray 102 and lower tray 104 and consequently the relative positions ofthe upper and lower jaws of the patient.

Lower Tray of Oral Appliance

FIG. 4 is a perspective view of one embodiment of the lower tray 104 oforal appliance 100. Lower tray 104 comprises integral fins 116-A and116-B. Lower tray 104 includes base plate 140.

Generally, base plate 140 is formed of any suitable material formanufacture of oral appliances known in the art. In some embodiments,base plate 140 is formed of a hard acrylic material.

In some embodiments, base plate 140 is formed from one part, two parts,three parts, or more than three parts. In some embodiments, the part(s)of base plate 140 are adjustable with an expansion mechanism. Generally,the expansion mechanism may be selected from any suitable expansionmechanism known in the art. In some embodiments, the expansion mechanismis selected from jackscrews, wires, wires bent with omega-shaped loops,and combinations thereof

In the embodiment of FIG. 4 , base plate 140 is formed in two parts,namely left part 140-A, and right part 140-B. As shown in FIG. 5 , leftpart 140-A and right part 140-B of base plate 140 are connected by anintervening midline jackscrew 142 that enables lower tray 104 to expandto account for palatal growth due to the use of 3-D axial springs 126.By adjusting jackscrew 142, left and right parts 140-A and 140-B moveaway from or toward the centerline of the dental arch to fit the lowertray to the dental arch of the patient.

In some embodiments, for example as shown in FIG. 5 , base plate 140includes extensions or overlays 144 of the plate body that symmetricallyoverlay the biting (occlusal) surfaces of at least two of the patient'steeth in the space where those teeth would normally contact the opposingteeth from the upper jaw. The thickness of the occlusal coverage rangesfrom approximately 0.5 mm to approximately 5.0 mm, as determined byorthodontic equilibration, and may be absent in certain locations orspots, if required. The base plate body itself has a thickness thatvaries, and ranges from about 1.0 mm to about 5.0 mm, depending upon thecomponents embedded within it.

In some embodiments, lower tray 104 of oral appliance 100 comprises oneintegral fin, two integral fins, three integral fins, four integralfins, or more than four integral fins. Generally, the integral finsprovide mandibular advancement. For example, as shown in FIG. 4 , lowertray 104 includes fins 116-A and 116-B that are positioned bilaterallyon the buccal side of the posterior of lower tray 104. Fin 116-A isformed integral with left part 140-A of base plate 140 and fin 116-B isformed integral with right part 140-B of base plate 140. Fins 116-A and116-B each individually include a metal fin, fin 118-A and fin 118-B,respectively, formed within the acrylic material of the respective finsto provide additional strength. In some embodiments, by encasing metalfin 118-A in the acrylic fin of fin 116-A and/or encasing metal fin118-B in the acrylic fin of fin 116-B, fin 116-A and fin 116-B and lowertray 104 are more streamlined compared to existing systems and therebyincreases patient comfort for providing mandibular advancement.

In some embodiments, fin 116-A and fin 116-B are each individuallyconfigured to be engaged by a corresponding adjustable positioner 114 onupper tray 102, as shown in FIG. 1A. In some embodiments, theconfiguration of the adjustable positioners 114 and the fins 116-A and116-B provide a stable mechanism for controlling mandibular advancementcompare to existing systems.

Three-Dimensional (3-D) Axial Springs

In some embodiments, the upper tray 102 and the lower tray 104 eachindividually comprise at least one spring. Generally, the spring isselected from any suitable spring known in the art to provide cyclicintermittent signaling that stimulates a patient's genome duringfunction. In some embodiments, the at least one spring comprises atleast one 3-D axial spring, such as those described in U.S. Pat. No.7,887,324.

In some embodiments, at least one of the upper tray 102 and the lowertray 104 include 3-D axial springs. In some embodiments, both the uppertray 102 and the lower tray 104 include 3-D axial springs. In someembodiments, the 3-D axial springs are constructed as shown in FIGS.6A-6C and as described below with reference to those figures. It isunderstood that the 3-D axial springs shown and described below withrespect to FIGS. 6A-6C are provided by way of example and not by way oflimitation.

FIG. 1B shows a perspective view of the oral appliance 100, whichincludes 3-D axial springs 126. Both the upper tray 102 and the lowertray 104 include 3-D axial springs 126.

In some embodiments, such as the embodiment shown in FIG. 6A, the 3-Daxial spring 126 used in upper tray 102 and lower tray 104 of the oralappliance 100 of FIG. 1B includes an active (compression-extension) axis154. During use, active axis 154 of the 3-D axial spring 126 isorientated at an angle approximately parallel to the long axis of thepalatal/lingual surface of the tooth and/or root, instead of lyingapproximately parallel to the transverse axis of the palatal/lingualsurface of the crown of said tooth and/or root.

In some embodiments, such as the embodiment shown in FIG. 6A, 3-D axialspring 126 includes a continuous spring body with an arm portion 150 ata proximal end 151 and a head portion 152 at a distal end 153. Armportion 150 includes initial arm 155 that is embedded in an acrylicbaseplate of upper tray 102 or lower tray 104, and a terminal arm 156that is also embedded in the same acrylic baseplate. Both initial arm155 and terminal arm 156 have approximately the same vertical axis:active axis 154.

In some embodiments, such as the embodiment shown in FIG. 6A, initialarm 155 and terminal arm 156 are connected by a plurality of undulatingU-bends 165 that form the body or head 152 of the 3-D axial spring 126.The plurality of U-bends 165 may vary in amplitude, thereby being biggeror smaller in size relative to each other. The plurality of U-bends 165may vary in frequency, being many or few in number. The plurality ofU-bends 165 may vary in characteristic, being differently shaped, suchas a ‘Z’ formation, a square waveform, a sinewave, a triangular wave, orany other appropriate shape that extends from side to side relative tothe central axis, namely active axis 154. The plurality of U-bends 165in the initial arm 155 and the terminal arm 156 of head portion 152 of3-D axial spring 126 lie in close proximity with respect to each otherfor the entire length of active axis 154 of 3-D axial spring 126. Duringuse, 3-D axial spring 126 lies on palatal/lingual surface of thecontiguous oral structures (mucosa) orientated at an angle approximatelyparallel to the long axis of the palatal/lingual surface of the toothand/or root. The head portion 152 of 3-D axial spring 126 intimatelycontacts the long axis of said palatal/lingual surface of said tooth.

As shown in FIG. 6B and FIG. 6C, the head portion 152 includes a firstwave-shaped segment 158 (made from a plurality of U-bends 165) extendingfrom the proximal end 151. As shown in FIG. 6C, the head portion 152 hasan active axis coincident with a long axis (active axis 154) of the 3-Daxial spring 126, and the head portion 152 further includes a secondwave-shaped segment 162 (made from a series of U-shaped bends 165)extending from the proximal end 151 and having an axis 160 arrangedabout 90-degrees from the active axis 154.

In many embodiments, the 3-D axial springs 126 comprise a resilientmaterial. Generally, the 3-D axial springs 126 may comprise a resilientmaterial composed of any suitable material known in the art. In someembodiments, the resilient material is selected from stainless steel,Titanium-Niobium-Aluminum (Ti—Nb—Al) alloys, Cobalt-Chromium-Nickelalloys (e.g. a Cobalt-Chromium-Nickel alloy known under the trade name“Elgiloy.®.” available from Elgiloy Specialty Alloys of Elgin, Ill.,USA), Nickel-Titanium (Ni—Ti) alloys, Ni—Ti wires that exhibits“super-elasticity”, Nickel-free beta-Titanium (Ni-free β-Ti) Alloys, andcombinations thereof.

In some embodiments, the 3-D axial springs 126 are formed from a wirecomposed of a single strand of alloy. In some embodiments, the 3-D axialsprings 126 are constructed from a braided wire composed of a pluralityof strands of a single alloy. In other embodiments, the 3-D axialsprings 126 are constructed from a braided wire composed of a pluralityof strands of a plurality of alloys.

Function of the Oral Appliance

Generally, oral appliance 100 performs at least two functions. First,oral appliance 100 enables changes to the form of the jaw and facialbones of a patient. Second, oral appliance 100 functions to provideimmediate relief from disordered breathing such as sleep apnea andsnoring through mandibular advancement.

In some embodiments, to treat a patient, oral appliance 100 is placedwithin the mouth of a patient so that overlays 137 and 144 contact atleast one tooth and the remainder of the plate body 130 or 140 is spacedfrom the patient's tissue, including the palate. Overlays 137 and 144prevent the patient's jaws from fully closing. Without being bound toany particular theory, it is believed that this contact of the teethwith the overlay causes intermittent forces to be applied to the bodyplate 130 or 140 and through the body plate 130 or 140 to the 3-D axialsprings 126 and to the teeth. This cyclic intermittent signalingstimulates the patient's genome during function, essentially each timethe patient speaks, swallows, chews, smiles etc., which is estimated tobe about 2,000 to 3,000 times per day/night. This frequent cyclicintermittent signaling on the facial and alveolar bones is believed tocause development of the facial and jaw bones where jaw development didnot fully occur during childhood. This bone development may include adescent of the palate (i.e., remodeling of the vault of the palatedownwardly toward the lower jaw); a widening of the palate; an upwardand outward remodeling of the body of the maxilla; and an increase inpalatal length, if necessary.

In some embodiments, upper tray 102 includes a lever arm coupled to avibrational meso-motor (not shown in the figures) capable of producingintermittent, cyclic signaling under control of a processor (not shownin the figures) to be applied to the 3-D axial springs. The motorprovides intermittent cyclic signaling to at least one of the 3-D axialsprings. In some embodiments, the motor provides intermittent cyclicsignaling to all of the 3-D axial springs of upper tray 102. In someembodiments, the vibrational meso-motor produces ultrasonic cyclicsignaling. In some embodiments, a meso-motor is incorporated into thelower tray 104 as well to provide intermittent cyclic signaling undercontrol of a processor to the 3-D axial springs of the lower tray 104.

In some embodiments, to provide relief from disordered breathing, sleepapnea and/or snoring, oral appliance 100 includes adjustable positioners114 on upper tray 102 and fins 116-A and 116-B on lower tray 104. Thepositioners 114 are set to an appropriate position to engage the fins116-A and 116-B on lower tray 104 to cause the lower jaw of the patientto be brought forward (mandibular advancement) to enlarge the airway ofthe patient. As oral appliance 100 is worn, the patient's airway and jawwill be modified. Thus, the positioners 114 will be adjusted fromtime-to-time so that the same beneficial effect can be maintained toimprove the patients breathing when the oral appliance is worn.

Use Tracking

For oral appliance 100 to be effective, the patient needs to use theoral appliance 100 as instructed by the provider. To assist the providerin tracking this use, in some embodiments, appliance 100 includes acompartment (not shown) formed on a side of one of the upper tray 102and the lower tray 104. In some embodiments, the compartment includes anopening (not shown) configured for receiving a compliance tracker (notshown). Generally, the compliance tracker measures patient treatmentcompliance using sensors. Generally, the compliance tracker may beselected from any suitable compliance tracker known in the art. In someembodiments, the compliance tracker is a DentiTrac compliance trackerfrom Braebon.

In some embodiments, the compliance tracker is configured and/oroperated as described in U.S. Patent Publication 2015/0169845, which isincorporated herein by reference. In some embodiments, the compliancetracker tracks and records the use of the appliance by the patient. Insome embodiments, the data recorded by the compliance tracker can bedownloaded and processed using a software program run by a provider todetermine the level of compliance in the patient's use of appliance 100.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat any arrangement, which is calculated to achieve the same purpose,may be substituted for the specific embodiment shown. This applicationis intended to cover any adaptations or variations of the presentinvention. Therefore, it is manifestly intended that this invention belimited only by the claims and the equivalents thereof.

This written description uses examples to illustrate the presentdisclosure, including the best mode, and also to enable any personskilled in the art to practice the disclosure, including making andusing any compositions or systems and performing any incorporatedmethods. The patentable scope of the disclosure is defined by theclaims, and may include other examples that occur to those skilled inthe art. Such other examples are intended to be within the scope of theclaims if they have elements that do not differ from the literallanguage of the claims, or if they include equivalent elements withinsubstantial differences from the literal language of the claims.

As used herein, the terms “comprises,” “comprising,” “includes,”“including,” “has,” “having,” “contains”, “containing,” “characterizedby” or any other variation thereof, are intended to cover anon-exclusive inclusion, subject to any limitation explicitly indicated.For example, a composition, mixture, process or method that comprises alist of elements is not necessarily limited to only those elements butmay include other elements not expressly listed or inherent to suchcomposition, mixture, process or method.

The transitional phrase “consisting of” excludes any element, step, oringredient not specified. If in the claim, such would close the claim tothe inclusion of materials other than those recited except forimpurities ordinarily associated therewith. When the phrase “consistingof” appears in a clause of the body of a claim, rather than immediatelyfollowing the preamble, it limits only the element set forth in thatclause; other elements are not excluded from the claim as a whole.

The transitional phrase “consisting essentially of” is used to define acomposition or method that includes materials, steps, features,components, or elements, in addition to those literally disclosed,provided that these additional materials, steps, features, components,or elements do not materially affect the basic and novelcharacteristic(s) of the claimed invention. The term “consistingessentially of” occupies a middle ground between “comprising” and“consisting of”.

Where an invention or a portion thereof is defined with an open-endedterm such as “comprising,” it should be readily understood that (unlessotherwise stated) the description should be interpreted to also describesuch an invention using the terms “consisting essentially of” or“consisting of.”

Further, unless expressly stated to the contrary, “or” refers to aninclusive or and not to an exclusive or. For example, a condition A or Bis satisfied by any one of the following: A is true (or present) and Bis false (or not present), A is false (or not present) and B is true (orpresent), and both A and B are true (or present).

Also, the indefinite articles “a” and “an” preceding an element orcomponent of the invention are intended to be nonrestrictive regardingthe number of instances (i.e. occurrences) of the element or component.Therefore “a” or “an” should be read to include one or at least one, andthe singular word form of the element or component also includes theplural unless the number is obviously meant to be singular.

As used herein, the term “about” means plus or minus 10% of the value.

What is claimed is:
 1. An oral appliance comprising: an upper trayconfigured to be positioned over an upper dental arch of a patient, theupper tray including first and second adjustable positioners locatedbilaterally on a buccal side of a posterior of the upper tray whereinthe first adjustable positioner extends from the right-side of the uppertray and the second adjustable positioner extends from the left-side ofthe upper tray; and a lower tray configured to be positioned over alower dental arch of the patient, the lower tray including first andsecond fins positioned bilaterally on a labial side of an anterior ofthe lower tray wherein the first fin extends from the right-side of thelower tray and the second fin extends from the left-side of the lowertray; wherein the first and second adjustable positioners are eachindividually configured to be adjusted to provide a desired amount ofmandibular advancement when the first and second adjustable positionersengage with the first and second fins, respectively; wherein the upperand lower trays are each individually coupled to at least one axialspring configured to contact a palatal/lingual surface of at least onetooth, wherein the at least one axial spring of the upper tray and theat least one axial spring of the lower tray are each individuallyconfigured to produce and transmit intermittent, cyclic forces to thepalatal/lingual surface of the at least one tooth; and wherein the upperand lower trays each individually comprise at least two sections coupledby an expansion mechanism to enable adjustment of the size of the upperand lower trays to account for palatal expansion and upper and lower jawdevelopment.
 2. The oral appliance of claim 1, wherein the first andsecond adjustable positioners each individually comprise a screwmechanism coupled to a spacer, wherein the screw mechanism moves thespacer forward or backward to a desired position so that an inclinedsurface of the spacer engages with a surface of the respective first andsecond fins to establish the desired amount of mandibular advancement.3. The oral appliance of claim 1, wherein the at least one axial springof the upper tray and the at least one axial spring of the lower trayeach individually comprise a 3-D axial spring comprising: a continuousspring body comprising an arm portion at a proximal end and a headportion at a distal end, wherein the head portion is adapted to contactthe palatal/lingual surface of the at least one tooth in an orientationapproximately parallel to the long axis of the tooth and anchored to oneof the upper and lower trays; wherein the head portion comprises a firstwave-shaped segment extending from the proximal end and having a firstaxis coincident with a long axis of the axial spring and a secondwave-shaped segment extending from the proximal end and having a secondaxis arranged about 90-degrees from the first axis.
 4. The oralappliance of claim 1, wherein the upper tray comprises a base platecomprising at least first and second parts, the base plate furthercomprising at least two overlays adapted to overlay an occlusal surfaceof posterior teeth bilaterally wherein one overlay is adapted to overlayan occlusal surface of a left-side of a jaw and the second overlay isadapted to overlay a second occlusal surface of a right-side of the jaw.5. The oral appliance of claim 4, wherein the first half and the secondhalf each further comprise a hard acrylic material.
 6. The oralappliance of claim 1, wherein the at least one axial spring of the uppertray and the at least one axial spring of the lower tray eachindividually comprise a wire composed of a single strand of alloy. 7.The oral appliance of claim 1, wherein the at least one axial spring ofthe upper tray and the at least one axial spring of the lower tray eachindividually comprise a braided wire composed of a plurality of strandsof alloy.
 8. The oral appliance of claim 1, wherein the at least oneaxial spring of the upper tray and the at least one axial spring of thelower tray are each individually configured to produce intermittent,cyclic forces to the palatal/lingual surface of the tooth byintermittent contact of opposing teeth in the maxillary and mandibulardental arches, during swallowing, speech, and/or mastication.
 9. Theoral appliance of claim 1, wherein the expansion mechanism is made of aself-expanding material.
 10. The oral appliance of claim 4, wherein theexpansion mechanism further comprises: an expansion jackscrew disposedintermediate to, and coupling, the first part of the base plate to thesecond part of the base plate.
 11. The oral appliance of claim 1,wherein at least one of the at least one axial spring of the upper trayand the at least one axial spring of the lower tray further comprises alever arm coupled to a vibrational meso-motor capable of producingintermittent, cyclic signaling.
 12. The oral appliance of claim 11,wherein the vibrational meso-motor produces ultrasonic cyclic signaling.13. The oral appliance of claim 1, further comprising a compartmentdisposed on at least one of the upper tray and the lower tray, whereinthe compartment is configured to receive a compliance tracking recorder.14. An oral appliance comprising: an upper tray configured to bepositioned over an upper dental arch of a patient, the upper trayincluding first and second adjustable positioners located bilaterally ona buccal side of a posterior of the upper tray wherein the firstadjustable positioner extends from the right-side of the upper tray andthe second adjustable positioner extends from the left-side of the uppertray; and a lower tray configured to be positioned over a lower dentalarch of the patient, the lower tray including first and second finslocated bilaterally on a labial side of an anterior of the lower traywherein the first fin extends from the right-side of the lower tray andthe second fin extends from the left-side of the lower tray; wherein thefirst and second adjustable positioners each individually comprise ascrew mechanism coupled to a spacer, wherein each screw mechanism isconfigured to set a position of the spacer to which it is coupled;wherein the position of the spacer provides a desired amount ofmandibular advancement when the first and second adjustable positionersengage with the first and second fins, respectively; wherein the uppertray and the lower tray each individually comprise at least one axialspring configured to contact a palatal/lingual surface of at least onetooth, wherein the at least one axial spring of the upper tray and theat least one axial spring of the lower tray are each individuallycoupled to the respective lower tray or upper tray, wherein the at leastone axial spring of the upper tray and the at least one axial spring ofthe lower tray are each individually configured to produce and transmitintermittent, cyclic forces to the palatal/lingual surface of the atleast one tooth; and wherein the upper tray and the lower tray eachindividually comprise at least two sections coupled by an expansionmechanism to enable adjustment of the size of the upper tray and thelower tray to account for palatal expansion and upper and lower jawdevelopment.
 15. The oral appliance of claim 14, wherein each spacerincludes an inclined surface that is configured to engage with a surfaceof the respective first and second fins to establish the desired amountof mandibular advancement.
 16. The oral appliance of claim 14, whereinthe at least one axial spring of the upper tray and the at least oneaxial spring of the lower tray each individually comprise a 3-D axialspring comprising: a continuous spring body comprising an arm portion ata proximal end and a head portion at a distal end, wherein the headportion is adapted to contact the palatal/lingual surface of the atleast one tooth in an orientation approximately parallel to the longaxis of the tooth and anchored to one of the upper and lower trays;wherein the head portion comprises a first wave-shaped segment extendingfrom the proximal end and having a first axis coincident with a longaxis of the axial spring and a second wave-shaped segment extending fromthe proximal end and having a second axis arranged about 90-degrees fromthe first axis.
 17. The oral appliance of claim 14, wherein the lowertray comprises a base plate comprising at least first and second parts,the base plate further comprising at least two overlays adapted tooverlay an occlusal surface of posterior teeth bilaterally wherein oneoverlay is adapted to overlay a first occlusal surface of a left-side ofa jaw and the second overlay is adapted to overlay a second occlusalsurface of a right-side of the jaw.
 18. The oral appliance of claim 17,wherein the first part and the second part each individually furthercomprise a hard acrylic material wherein the first fin is formedintegral with the first part and the second fin is formed integral withthe second part.
 19. The oral appliance of claim 14, wherein the atleast one axial spring of the upper tray and the at least one axialspring of the lower tray each individually comprise a wire composed of asingle strand of alloy.
 20. The oral appliance of claim 14, wherein theat least one axial spring of the upper tray and the at least one axialspring of the lower tray each individually comprise a braided wirecomposed of a plurality of strands of alloy.
 21. The oral appliance ofclaim 14, wherein the at least one axial spring of the upper tray andthe at least one axial spring of the lower tray are each individuallyconfigured to produce intermittent, cyclic forces to the palatal/lingualsurface of the tooth by intermittent contact of opposing teeth in themaxillary and mandibular dental arches, during swallowing, speech,and/or mastication.
 22. The oral appliance of claim 14, wherein theexpansion mechanism is made of a self-expanding material.
 23. The oralappliance of claim 17, wherein the expansion mechanism furthercomprises: an expansion jackscrew being disposed intermediate to, andcoupling, the first part of the base plate to the second part of thebase plate.